05/05/2022    Allen Jacobs, DPM

Hyperbaric Oxygen is the "Nectar of the Gods": MA Podiatrist

The suggestion that hyperbaric oxygen is the
“nectar of the gods” is incredulous. The
retrospective studies examining the utilization of
HBO for the management of DFU are at best
controversial. The largest published retrospective
studies demonstrate no benefit to system HBO, and
no benefit whatsoever to topical HBO. Such studies
have demonstrated no reduction in amputation
rates, or advantage of HBO to comprehensive wound
care.

The International Working Group on the Diabetic
Foot most recent recommendations stated that the
indications for systemic HBO were “weak”, and for
topical HBO non-existent. HBO therapy is never
performed in a vacuum, and is adjunctive therapy,
utilized with other wound care therapies (eg:
debridement, antibiotics, nutritional therapies,
grafts, wound dressings, etc.).

Hyperbaric oxygen has made millionaires out of
those with ownership positions. HBO is attractive
not because it maintains literature support for
use, but rather the fact that it generates income
for hospitals, HBO center corporate owners, and
physicians or podiatrists “supervising” the
therapy. Careful exclusion of patients who would
benefit without HBO therapy conversely reduces
hospital, corporate, and physician/podiatrist
income.

The ethical use of HBO therapy includes a priori
exclusion of patients who would otherwise heal
with comprehensive wound care. Having provided
wound care in a center with HBO available, and
having what I believe to be extensive involvement
in wound care, I can state with certainty that
when HBO is available, there is generally a “play
or be benched” pressure to make referrals for HBO
therapy. We have an ethical responsibility to
reduce the cost of wound care to society generally
and to each patient individually.

For most patients, in my experience, HBO therapy
unnecessarily increases the cost of care without
benefit to many is not most patients receiving
such therapy. The retrospective studies and the
conclusions of the IWGDF are what they are. As
football coach Bill Parsells famously stated; “you
are what your record says you are”.

Allen Jacobs, DPM, St. Louis, MO

Other messages in this thread:

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05/11/2022    David E. Samuel, DPM

Hyperbaric Oxygen is the "Nectar of the Gods": MA Podiatrist (Allen Jacobs. DPM)

Thanks Dr. Jacobs for those stats. This is so
classic in that therapies that could have some
benefits in very specific circumstances are
destroyed and become not payable for over
utilization purely based on the mighty dollar.
This will happen to graft codes soon enough,
putting thousands of dollars of quality products
on ulcers that are not properly off-loaded,
compressed, debrided, etc., and would never heal
until a met head is excised or vascular status
maximized, or compression therapy initiated, to
allow for healing.

Wonder why they want to limit applications now?
Keep using them 8 times on your patients who walk
in the door in their normal shoes, carrying their
knee scooter or holding their crutches/walker,
swearing they ‘hardly’ walk on it. Why is PRP or
amniotic injections considered experimental and
not covered by so many, if not all carriers?

Because for a few buck profit, PRP, etc. would be
abuse for so many simple things, that a few ccs of
dex or Kenalog would otherwise fix. Approving
these potential very beneficial things, opens a
Pandora’s box for the carriers, for what would
likely be over utilized, costing astronomical
amounts, and therefore will likely and
unfortunately not ever be an approved option for
us to use judiciously.

I have seen the wound center dive patients
30/45/60 dives and still have yet to see a
vascular surgeon to eval, stent or bypass to
maximize flow, then MAYBE HBO might have a
benefit. Now I understand it is quite hard to get
approval for dives. Or my favorite waste of
dollars and time is the MRI ordered to DIAGNOSE
OSTEO, (which still makes me scratch my head as to
when this was ever taught or known to be true or
why it is ordered so frequently to ‘Look for
osteo’, when it is not diagnostic).

I am not sure if it still is, but a diagnosis of
osteo also used to be a qualifier for HBO
treatments, so of course, get an MRI that will
light up purely based on marrow edema, secondary
to met head pressure under the ulcer, thus
‘proving’ osteo to allow for HBO reimbursement. Or
cover your butt when your x-ray report comes back
from the radiologist that says ‘no clinical
evidence of osteo. MRI suggested for further
evaluation’. They get paid again for an MRI.

You are stuck now treating a study, that you know,
or should know, proves nothing. Just a thought,
maybe go with the negative xray you reviewed,
under an ulcer, that you can see on debridement is
not into the deep structures/bone. Why not
offload, treat locally, check films in a few more
weeks, even some oral antibiotics.

If by chance, it gets deeper or new films now
shows your initial assessment is not right, and
now you finally see some periosteal changes, what
harm has occurred. You told your patient, MRIs are
not diagnostic. We’ll give you a little
antibiotics. We are going to treat this locally
and aggressively and it might be there, but the
only way to be sure is with a biopsy.

But in light of having an open wound, a biopsy
also has a risk to potentially introduce
infection, so why risk that and we will just treat
and be vigilant and look for changes later. We can
always biopsy and/or resect some bone and continue
treatment, if changes are seen. Would you
personally agree to radical debridement of your
metatarsal, toe, etc. based on an MRI? Good
documentation and a logical medically based game
plan is a solid defense for those thinking
defensive medicine, as I understand the world we
live in.

Also, perhaps have an educational discussion with
your radiologist, asking how is this DIAGNOSTIC
and perhaps in the future just read the findings
and if they are inclined to want to leave a
differential fine. But a ‘rule out osteo’ Rx is
going to come back osteo if the met head lights up
on an MRI, contrast or not, 9/10 x based on just
pressure.

I agree also with what Dr. Jacobs added. Use your
education. Use what you know is right and stand by
it, even educate your PCPs, Radiologist, ID docs,
medical residents, etc., leaving clear
explanations in your notes as to why treating a
study is not how to do it, and explaining the
game plan and logic behind it. It can save you and
your patients, time, money, and potentially
unnecessary treatments/surgery. If practice is
based on fear, and worrying about what others
think, (that may not be as versed in some areas as
you are), MRIs would be ordered for every headache
for fear of missing a brain tumor.

David E. Samuel, DPM, Springfield, PA

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05/10/2022    Steven Kravitz, DPM

Hyperbaric Oxygen is the "Nectar of the Gods": MA Podiatrist (Elliot Udell, DPM)

Dr. Udell points to an interesting but realistic
question and the economic drivers that are
unfortunately involved in medical decision making.
By economic drivers I also reference political
relationship between physicians in the hospital
setting. That includes the need for continued
referral for business.

However you still can stand on your 2 feet and
explain and present the articles that support your
position. There are many articles on HBO.
Unfortunately the vast majority (according to the
major research articles) are poorly constructed
and do not provide valid evidence to support the
use of HBO.

I believe the article I referenced below is the
gold standard and it was revisited in 2013 with an
online version and updated supplemental material.
is worth the read, extensive with over 6,000
patients. There no evidence that HBO has any
effect on the diabetic foot for healing of ulcers.
It also challenges much of the "poor" research
published this in the subject area.

The reference below was republished in 2013 with
updated material by American Diabetes Association
in Diabetes Care.

Should you be faced with the question again, this
is a good article to present it to the hospital
physician and the staff as well. Arguably one the
best studies on subject to date.

One last point is that I have used HBO on a
selected few patients where I believe it helped
improve wound healing when a degree ischemia
involved responded to the hyperbaric oxygen
atmosphere. In conclusion, nothing is black and
white. There are shades of gray and that requires
experience and the right sense of ethics as to how
to treat. But at the end of the day these
decisions need to be medically driven. As you
point out in your article, the pressure from the
wound healing centers to utilize this therapy
needs to be addressed and corrected.

Reference:
Lack of effectiveness of hyperbaric oxygen therapy
for the treatment of diabetic foot ulcer and the
prevention of amputation a cohort study); David
Margolis, MD et. al. American diabetes
Association, update 2013.

Steven Kravitz, DPM, Winston Salem area. NC

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05/09/2022    Allen Jacobs. DPM

Hyperbaric Oxygen is the "Nectar of the Gods": MA Podiatrist (Elliot Udell)

With reference to hyperbaric oxygen therapy, over
a decade ago, the OIG reported the following
compliance issues:
1. Billing Medicare for the use of HBO for non-
covered services;
2. Inadequate documentation to support the medical
necessity for HBO;
3. Giving patients more HBO treatments than
necessary;
4. Failing to perform the appropriate testing or
treatment prior to HBO;
5. Not having a physician present during the HBO
treatment;
6. 32% of all HBO payments were inappropriately
billed;
7. 11% of payments were for excessive treatments;
8. 37% lack of sufficient progress to justify
continuing treatment with HBO.

The Healogics HBO 22.51 million dollar false
claims act liability for improper billing of HBO
therapy (Department of Justice June 2018- Inited
States ex tel. Van Raallte, et al. v. Healogics
Inc. 14-cv-283 (M.D. Fla) and United States ex
tel. Wilcox v. Healogics, Inc, et al. 15-ev-1510
(M.D. Fla ) exemplify the economic impact of HBO
therapy in the wound healing stratosphere.

On another note, we need to stand on the education
and expertise that accompanies the DPM degree. I
for one do not believe that the MD degree
supersedes the DPM degree for the diagnosis and
treatment of foot pathology. It is unfortunate
that the fear of litigation trumped Dr. Udell’s
best judgment for patient care in his described
case.

The DPM degree is a trust placed by the state in
your education and expertise in diagnosis and
treatment of foot disorders. The DPM is empowered
to determine educational standards and testing for
the DPM degree, licensure requirements,
requirements for CME, requirements for board
certification. The DPM degree grants you the
authority to employ any diagnostic or
interventional therapies which you determine to be
appropriate.

Allen Jacobs. DPM, St. Louis, MO